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Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00098059
Recruitment Status : Completed
First Posted : December 3, 2004
Results First Posted : May 6, 2009
Last Update Posted : April 25, 2013
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Herpes Simplex
Intervention Drug: Famciclovir
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir)
Hide Arm/Group Description Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled. Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
Period Title: Overall Study
Started 27 47
Completed 27 46
Not Completed 0 1
Arm/Group Title Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir) Total
Hide Arm/Group Description Each patient in Part A received a single dose of famciclovir (12.5 mg/kg). Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose. Total of all reporting groups
Overall Number of Baseline Participants 27 47 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 47 participants 74 participants
1 to <2 years 4 13 17
2 to <6 years 13 16 29
6 to <=12 years 8 18 26
13 to <=18 years 2 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 47 participants 74 participants
Female
17
  63.0%
24
  51.1%
41
  55.4%
Male
10
  37.0%
23
  48.9%
33
  44.6%
1.Primary Outcome
Title Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Hide Description A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Time Frame 8 hours and 24 hours after study drug administration (Part A)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to <= 18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 13 8 2
Measure Type: Number
Unit of Measure: participants
Patients with AEs 0 2 1 2
Gastrointestinal disorders 0 1 0 1
Nervous system disorders 0 0 1 1
General disorders and administration site 0 0 0 1
Infections and infestations 0 1 0 0
Skin and subcutaneous tissue disorders 0 1 0 0
2.Primary Outcome
Title Maximum Observed Plasma Concentration of Penciclovir (Cmax)
Hide Description PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to <= 18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 13 8 2
Mean (Full Range)
Unit of Measure: μg/mL
2.84
(1.42 to 4.47)
2.44
(0.42 to 3.81)
2.82
(1.52 to 3.79)
1.89
(1.06 to 2.72)
3.Primary Outcome
Title Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
Hide Description PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to < =18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 13 8 2
Median (Full Range)
Unit of Measure: hours
1.21
(1.00 to 1.50)
1.07
(1.00 to 4.03)
1.00
(1.00 to 2.07)
1.47
(0.97 to 1.97)
4.Primary Outcome
Title Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Hide Description PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes 26 of 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to <= 18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 12 8 2
Mean (Full Range)
Unit of Measure: (μg/mL)h
6.17
(3.43 to 8.99)
6.85
(3.19 to 9.12)
8.15
(6.49 to 9.71)
5.93
(4.84 to 7.01)
5.Primary Outcome
Title Apparent Oral Clearance of Penciclovir (CL/F)
Hide Description PK parameter; penciclovir is the active metabolite of famciclovir.
Time Frame Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes 26 of 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to <= 18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 12 8 2
Mean (Full Range)
Unit of Measure: L/h
20.8
(11.0 to 28.8)
25.1
(18.1 to 33.3)
43.7
(32.4 to 60.8)
68.8
(56.2 to 81.5)
6.Primary Outcome
Title Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
Hide Description PK parameter; penciclovir is the active metabolite of famciclovir
Time Frame Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes 26 of 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <=12 Years 13 to <= 18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 12 8 2
Mean (Full Range)
Unit of Measure: hours
1.09
(1.01 to 1.18)
1.36
(1.10 to 1.70)
1.60
(1.30 to 2.11)
1.86
(1.60 to 2.12)
7.Primary Outcome
Title Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Hide Description A patient with multiple AEs within the primary system organ class is counted only once in total row.
Time Frame Administered 2 times daily over 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes 47 patients enrolled in Part B of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <13 Years 13 to <=18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 13 16 18 0
Measure Type: Number
Unit of Measure: participants
Patients with AEs 6 8 12
Gastrointestinal disorders 4 3 6
Nervous system disorders 0 2 5
General disorders and administration site 3 1 1
Respiratory, thoracic and mediastinal disorders 1 1 2
Infections and infestations 3 0 0
Skin and subcutaneous tissue disorders 1 2 0
Vascular disorders 0 0 2
Injury, poisoning and procedural complications 0 1 1
Investigations 1 0 0
Metabolism and nutrition disorders 1 0 0
8.Secondary Outcome
Title Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Hide Description Overall acceptability of the study medication was determined by caretaker response.
Time Frame Day 1, after swallowing the dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 27 patients enrolled in Part A of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <13 Years 13 to <=18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 13 8 2
Measure Type: Number
Unit of Measure: participants
Badly 1 4 0 2
Neither bad nor good 1 1 4 0
Well 2 8 4 0
9.Secondary Outcome
Title Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Hide Description Overall acceptability of the study medication was determined by caretaker response.
Time Frame Day 1 at clinic: after swallowing first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 47 patients enrolled in Part B of the study.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <13 Years 13 to <=18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 13 16 18 0
Measure Type: Number
Unit of Measure: participants
Badly 9 6 7
Neither bad nor good 2 1 2
Well 2 9 9
10.Secondary Outcome
Title Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Hide Description Overall acceptability of study medication was determined by caretaker response.
Time Frame Day 8 at home: after swallowing last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups.
Arm/Group Title 1 to < 2 Years 2 to <6 Years 6 to <13 Years 13 to <=18 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 13 16 18 0
Measure Type: Number
Unit of Measure: participants
Badly 7 5 3
Neither bad nor good 3 3 3
Well 3 7 11
Time Frame Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir)
Hide Arm/Group Description Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled. Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
All-Cause Mortality
Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/47 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Part A (Single-dose of Famciclovir) Part B (Multiple-dose of Famciclovir)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/27 (18.52%)   23/47 (48.94%) 
Gastrointestinal disorders     
Abdominal pain upper  1  2/27 (7.41%)  2/47 (4.26%) 
Vomiting  1  0/27 (0.00%)  5/47 (10.64%) 
Diarrhea  1  0/27 (0.00%)  4/47 (8.51%) 
Nausea  1  0/27 (0.00%)  3/47 (6.38%) 
General disorders     
Pyrexia  1  1/27 (3.70%)  2/47 (4.26%) 
Infections and infestations     
Furuncle  1  1/27 (3.70%)  0/47 (0.00%) 
Nervous system disorders     
Dizziness  1  1/27 (3.70%)  0/47 (0.00%) 
Headache  1  2/27 (7.41%)  4/47 (8.51%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/27 (0.00%)  3/47 (6.38%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/27 (3.70%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098059    
Other Study ID Numbers: CFAM810B2303
First Submitted: December 2, 2004
First Posted: December 3, 2004
Results First Submitted: February 2, 2009
Results First Posted: May 6, 2009
Last Update Posted: April 25, 2013